Self-reported Pre-exposure Prophylaxis Research Articles

Concordance between daily diary reported pre-exposure prophylaxis intake and intraerythrocytic tenofovir diphosphate in the Amsterdam Pre-exposure Prophylaxis demonstration project.

We assessed the association and concordance between self-reported oral pre-exposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations. AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020). Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa. Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration ( β = 0.77, 95% CI = 0.70-0.84, P < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate ( κ = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect ( κ = 0.83, 95% CI 0.76-0.90). Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals.

Optimal strategies to improve uptake of and adherence to HIV prevention among young people at risk for HIV acquisition in the USA (ATN 149): a randomised, controlled, factorial trial

Pre-exposure prophylaxis (PrEP), condom use, post-exposure prophylaxis (PEP), and sexual partner reduction help to prevent HIV acquisition but have low uptake among young people. We aimed to assess the efficacy of automated text messaging and monitoring, online peer support, and strengths-based telehealth coaching to improve uptake of and adherence to PrEP, condom use, and PEP among adolescents aged 12-24 years at risk of HIV acquisition in Los Angeles, CA, USA, and New Orleans, LA, USA. We conducted a four-arm randomised controlled factorial trial, assessing interventions designed to support uptake and adherence of HIV prevention options (ie, PrEP, PEP, condom use, and sexual partner reduction). We recruited young people aged 12-24 years who were at risk of HIV acquisition from 13 community-based organisations, adolescent medicine clinics, and organisations serving people who are unstably housed, people who were previously incarcerated, and other vulnerable young people, and through dating apps, peer referrals, and social venues and events in Los Angeles, CA, USA, and New Orleans, LA, USA. Young people who tested seronegative and reported being gay, bisexual, or other men who have sex with men, transgender men or women, or gender diverse (eg. non-binary or genderqueer) were eligible for inclusion. Participants were randomly assigned to one of four intervention groups in a factorial design: automated text messaging and monitoring (AMMI) only, AMMI plus peer support via private social media, AMMI plus strengths-based telehealth coaching by near-peer paraprofessionals, or AMMI plus peer support and coaching. Assignment was further stratified by race or ethnicity and sexual orientation within each interviewer's group of participants. Participants were masked to intervention assignment until after baseline interviews when offered their randomly assigned intervention, and interviewers were masked throughout the study. Interventions were available throughout the 24-month follow-up period, and participants completed baseline and follow-up assessments, including rapid diagnostic tests for sexually transmitted infections, HIV, and substance use, at 4-month intervals over 24 months. The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use with all partners, PEP prescription and adherence, and number of sexual partners in participants with at least one follow-up. We used Bayesian generalised linear modelling to assess changes in outcomes over time comparing the four study groups. This study is registered with ClinicalTrials.gov (NCT03134833) and is completed. We screened 2314 adolescents beginning May 1, 2017, to enrol 1037 participants (45%) aged 16-24 years between May 6, 2017, and Aug 30, 2019, of whom 895 (86%) had follow-up assessments and were included in the analytical sample (313 assigned to AMMI only, 205 assigned to AMMI plus peer support, 196 assigned to AMMI plus coaching, and 181 assigned to AMMI plus peer support and coaching). Follow-up was completed on Nov 8, 2021. Participants were diverse in race and ethnicity (362 [40%] Black or African American, 257 [29%] Latinx or Hispanic, 184 [21%] White, and 53 [6%] Asian or Pacific Islander) and other sociodemographic factors. At baseline, 591 (66%) participants reported anal sex without a condom in the past 12 months. PrEP use matched that in young people nationally, with 101 (11%) participants reporting current PrEP use at baseline, increasing at 4 months to 132 (15%) and continuing to increase in the AMMI plus peer support and coaching group (odds ratio 2·31, 95% CI 1·28-4·14 vs AMMI control). There was no evidence for intervention effect on condom use, PEP use (ie, prescription or adherence), PrEP adherence, or sexual partner numbers. No unanticipated or study-related adverse events occurred. Results are consistent with hypothesised synergistic intervention effects of evidence-based functions of informational, motivational, and reminder messaging; peer support for HIV prevention; and strengths-based, goal-focused, and problem-solving telehealth coaching delivered by near-peer paraprofessionals. These core functions could be flexibly scaled via combinations of technology platforms and front-line or telehealth HIV prevention workers. Adolescent Medicine Trials Network for HIV/AIDS Interventions, US National Institutes of Health.

165. Relationships Between Self-Perceived Risk of HIV, Behavioral Risk of HIV, and Self-Reported Pre-Exposure Prophylaxis (PREP) Utilization Among Young Men Who Have Sex With Men of Color: Preliminary Findings From a Prospective Cohort Study

165. Relationships Between Self-Perceived Risk of HIV, Behavioral Risk of HIV, and Self-Reported Pre-Exposure Prophylaxis (PREP) Utilization Among Young Men Who Have Sex With Men of Color: Preliminary Findings From a Prospective Cohort Study

Physical and mental health of long-term users of HIV preexposure prophylaxis in Australia.

HIV preexposure prophylaxis (PrEP) is highly effective at preventing HIV. We aimed to assess mental and physical health among long-term PrEP users in Australia's X-PLORE cohort. In early 2021, 1485 X-PLORE participants were emailed a survey covering demographics, sexual practices, ongoing PrEP use, physical and psychological diagnoses received since commencing PrEP, substance use, and impacts of the COVID-19 pandemic. Current anxiety and depression were assessed using GAD-7 and PHQ-9 questionnaires. Of 476 participants (completion rate 32.1%), 99.8% were cis-gender men. Median PrEP use duration was 48 months (2002 person-years), with 81.7% currently using PrEP. PrEP-related toxicity was uncommon: 2.9% reported bone fractures, 1.3% low bone density, and 4.0% reported kidney problems, largely not necessitating PrEP cessation. Most (92.0%) rated their health as 'good' to 'excellent', and 22.6% reported improved health since starting PrEP, often because of improved mental health. Only 6.2% reported deterioration in health since starting PrEP, largely unrelated to PrEP. The most common diagnoses were hypertension (9.9%), depression (13.2%) and anxiety (14.9%); 17% had PHQ-9 scores indicating current moderate-to-severe depression, which was associated with unemployment [adjusted odds ratio (aOR) 3.90], regular cannabis use (aOR 2.49), and having ceased PrEP (aOR 2.13). Among long-term PrEP users, of which over 80% were currently using PrEP, self-reported PrEP toxicity was uncommon. With almost one in five PrEP users categorized as having depression, and with higher risk among those having ceased PrEP, we recommend routine screening for depression and anxiety in PrEP users and corresponding follow-up of patients no longer attending for PrEP.

Trust in the provider and accurate self-reported PrEP adherence among adolescent girls and young women in South Africa and Zimbabwe: HPTN 082 study

BackgroundTrust is an important cornerstone of patient-provider communication. Accurate reporting of pre-exposure prophylaxis (PrEP) adherence is vital for providers to determine who needs adherence support, especially adolescent girls and young women (AGYW) disproportionately affected by newly diagnosed HIV.MethodsThis is a secondary analysis of the HPTN 082 open-label PrEP demonstration trial. From 2016–2018, 451 AGYW aged 16–25 years were enrolled in South Africa (Cape Town and Johannesburg) and Zimbabwe (Harare). PrEP was initiated by 427, and 354 (83%) had month three patient-reported adherence responses and intracellular tenofovir diphosphate (TFV-DP) measurements. The patient-reported adherence response to ‘In the past month, how often did you take the tablet?’ was dichotomized as ‘high’ if the response was every day or most days, and ‘low’ if some days or not many days or never. The biomarker marker evidence of adherence in dried blood spots was defined as ‘high’ if TFV-DP ≥ 700, and ‘low’ if < 350 fmol/punch. We used multinomial logistic regression to examine if trust in the PrEP provider was associated with concordance between patient-reported adherence and intracellular tenofovir-diphosphate (TFV-DP).ResultsAGYW who reported trust in their providers were almost four-fold (aOR 3.72, 95% CI 1.20–11.51) more likely to have concordant adherence (high self-reported adherence and high TFV-DP concentrations) compared to discordant non-adherence (high self-reported adherence and low TFV-DP concentrations).ConclusionEducation and training of providers to build trusting relationships with AGYW may lead to more accurate reporting of PrEP adherence. With accurate reporting, adequate support can be provided to bolster adherence.Trial registrationClinicalTrials.gov Identifier: NCT02732730.

Novel Latent Profile Analysis of a Test of Concept, Stigma Intervention to Increase PrEP Uptake Among Black Sexual Minority Men.

Pre-exposure prophylaxis (PrEP) has demonstrated efficacy for HIV prevention, yet uptake of PrEP among populations in urgent need of prevention tools (eg, Black sexual minority men) is limited, and stigma and medical mistrust remain strong barriers to accessing PrEP. To evaluate a test of concept brief intervention to address stigma and medical mistrust as barriers to PrEP uptake using novel latent profile analysis. Participants (N = 177) residing in the southeastern US were randomized to 1 of 4 arms to establish the potential impact of a brief, stigma focused counseling intervention (referred to as Jumpstart ) to increase PrEP uptake. We estimated intervention effect size (Cramer's V) for PrEP uptake and then explored differential intervention effects across latent profiles of psychosocial barriers to PrEP use. The intervention resulted in small, but meaningful effect size, with self-reported PrEP uptake increasing across Jumpstart conditions with the control condition reporting 24% uptake and Jumpstart plus text/phone calls (the most intensive intervention arm) reporting 37% uptake, and a similar pattern emerging for biologically confirmed PrEP use. Among participants 30 and older, Jumpstart participants were more likely to move to a postintervention profile with fewer barriers than control participants and reported the highest uptake of PrEP. Addressing social/emotional barriers to PrEP uptake is an essential component of bridging the gap between advances being made in biomedical forms of HIV prevention, and establishing and supporting access to those advances.

HIV pre-exposure prophylaxis persistence and adherence among men who have sex with men in 4 U.S. cities.

HIV pre-exposure prophylaxis (PrEP) persistence and adherence are critical to ending the HIV epidemic in the United States. In 2017 National HIV Behavioral Surveillance, HIV-negative men who have sex with men (MSM) in 4 U.S. cities completed a survey, HIV testing, and dried blood spots (DBS) at recruitment. We assessed three PrEP outcomes: persistence (self-reported PrEP use at any time in the past 12 months and had tenofovir, emtricitabine, or tenofovir diphosphate (TFV-DP) detected in DBS), adherence at ≥4 doses/week (self-reported past-month PrEP use and TFV-DP concentration ≥700 fmol/punch), and adherence at 7 doses/week (self-reported past-month PrEP use and TFV-DP concentration ≥1250 fmol/punch). Associations with key characteristics were examined using log-linked Poisson regression models with generalized estimating equations. Among 391 MSM who took PrEP in the past year, persistence was 80% and was lower among MSM who were younger, had lower education, and had fewer sex partners. Of 302 MSM who took PrEP in the past month, adherence at ≥4 doses/week was 80% and adherence at 7 doses/week was 66%. Adherence was lower among MSM who were younger, were Black, and had fewer sex partners. Although persistence and adherence among MSM were high, 1 in 5 past-year PrEP users were not persistent and 1 in 5 past-month PrEP users were not adherent at levels that would effectively protect them from acquiring HIV (i.e., ≥4 doses/week). Efforts to support PrEP persistence and adherence should include MSM who are young, are Black, and have less education.

216 Relationships Between Self-Perceived Risk of HIV, Behavioral Risk of HIV, and Self-Reported Pre-Exposure Prophylaxis (PrEP) Utilization Among Young Men Who Have Sex with Men of Color at Risk for HIV Infection: Findings From a Prospective Cohort Study

OBJECTIVES/GOALS: To improve our delivery of HIV prevention services by evaluating associations between self-perceived risk of HIV, objective risk for HIV based on sexual risk, and self-reported lifetime PrEP use. This will expand our current understanding of an essential component of decision making for PrEP uptake in young men who have sex with men (YMSM). METHODS/STUDY POPULATION: The population consists of participants in the Healthy Young Men (HYM) observational cohort study (16-24-year-old YMSM of color at risk for HIV in Los Angeles). Secondary analysis was conducted using an existing data set to test associations between self-perceived risk of HIV, behavioral sexual risk, and self-report of lifetime PrEP use at baseline. RESULTS/ANTICIPATED RESULTS: The HYM cohort consists of 397 HIV-negative young men who have sex with men from Los Angeles; 21% identify as African American/Black, 59% as Latinx, and 20% as multiethnic. Of these participants, 90% were aware of PrEP and 86% were eligible for PrEP according to CDC behavioral risk criteria; however, only 23% had ever been prescribed PrEP. We hypothesize that those who have utilized PrEP will report higher self-perceived risk of HIV infection and will have stronger correlation between self-perceived and objective risk for HIV. Associations will be tested using appropriate chi-square tests. DISCUSSION/SIGNIFICANCE: Self-perceived risk of HIV is proposed as a strong predictor of engagement in HIV prevention. This has been widely understudied in youth in the context of accessing PrEP. A better understanding of the role of self-perceived risk is essential to create and improve interventions to increase PrEP uptake as well as to improve PrEP service delivery for youth.

Correlates of self-reported and biomarker based adherence to daily oral HIV pre-exposure prophylaxis among a cohort of predominantly men who have sex with men in Nigeria.

HIV pre-exposure prophylaxis (PrEP) significantly reduces the risk of HIV acquisition. However, studies have demonstrated discordance between self-reported measures and biomedical benchmarks of PrEP adherence. We estimated the correlation between self-reported PrEP adherence and PrEP biomarkers and explored factors associated with adherence among men who have sex with men (MSM) in Nigeria. TRUST-PrEP, an open-label, prospective study; conducted in Abuja between April 2018 and May 2019. MSM ≥ 18 years with substantial HIV risk were enrolled. Participants reported PrEP adherence in the last month using a 4-point scale from "poor" to "perfect" and serum samples for PrEP biomarkers were collected at months 3 and 9. Serum tenofovir concentration was measured by liquid chromatography-tandem mass spectrometry and considered protective for adherence if ≥ 4.2 ng/ml. Spearman's rank correlation was used to estimate correlation between self-reported adherence and measured tenofovir levels. Generalized estimating equations with a logit link was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for associations between self-reported adherence and laboratory-measured adherence. A total of 219 MSM with median age 23 (interquartile range 20-27) years had at least one PrEP biomarker assay. Only 66/219 (30%) had at least one record of protective tenofovir concentration. Correlation between tenofovir and self-reported adherence at 3 and 9 months were 0.1 and 0.02 respectively. Furthermore, 17/219 (8%,) and 49/219 (22%) had serum tenofovir of 4.2-35.4 ng/mL and ≥ 35.5 ng/mL, corresponding to at least 4 and 7 days' PrEP use in a week, respectively. PrEP adherence was higher among participants introduced to PrEP in the clinics compared with communities (aOR: 8.35, 95%CI: [3.24, 21.5]) and those with same-sex practices family disclosure (aOR: 3.60 95% CI: [1.73, 7.51]). Self-reported PrEP adherence poorly correlated with biomarkers. Facilitating clinic-based PrEP introduction and disclosure of same-sex practices to family among MSM may improve PrEP adherence.

Impact and cost-effectiveness of the national scale-up of HIV pre-exposure prophylaxis among female sex workers in South Africa: a modelling analysis.

In 2016, South Africa (SA) initiated a national programme to scale-up pre-exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost-effectiveness of this programme, including future scale-up scenarios and the potential detrimental impact of the COVID-19 pandemic. A compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self-reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down-adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0-70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2-87.6% efficacy). FSWs can transition between adherence levels, with lower loss-to-follow-up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40-0.85; TAPS data). The model was calibrated to monthly data on the national scale-up of PrEP among FSWs over 2016-2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016-2020) and the future impact (2021-2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost-effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016-2040) of the current PrEP provision. Calibrated to national data, model projections suggest that 2.1% of HIV-negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35-0.57%) of HIV infections among FSWs over 2016-2020 or 605 (444-840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99-23.29). PrEP is cost-saving, with $1.42 (1.03-1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572-9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7-11.6%) and impact increases 4.3 times with 24,114 (15,308-38,107) infections averted by 2040. Our findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services.

Pre-exposure prophylaxis use among female sex workers in Gulu city, Uganda: a community-based cross-sectional study.

Pre-exposure prophylaxis (PrEP) is an important intervention for reducing the risk of HIV transmission among high-risk populations such as female sex workers in Africa, where HIV prevalence remains high. We aimed to assess the use of PrEP among female sex workers in Gulu, Uganda. In this community-based cross-sectional study, we included HIV-negative female sex workers purposely selected from hotspots within Gulu city, Uganda between February and March 2023. A semi-structured questionnaire was administered to collect data on sociodemographic characteristics, reproductive data, sexual practices, and self-reported PrEP use in the past 3 months. Symptoms of depression were screened using Patient Health Questionnaire-2 tool. Predictors of PrEP use was determined using modified Poisson regression analysis model. p < 0.05 was considered statistically significant. We enrolled 273 female sex workers with a median age of 27 (interquartile range: 24-32) years. Overall, 181 (66.3%) participants used PrEP. PrEP use was associated with; regular source of income beside sex work [adjusted prevalence ratio (aPR): 3.7, 95% confidence interval (CI): 2.11-6.35, p < 0.001], being in a polygamous marriage (aPR: 6.9, 95% CI: 1.32-35.77, p = 0.022), practicing sex work in both rural and urban areas (aPR: 2.5, 95% CI: 1.49-4.35, p < 0.001), having symptoms of depression (aPR: 3.3, 95% CI: 1.43-7.74, p = 0.005), and use of postexposure prophylaxis (PEP) in the past 12 months (aPR: 0.31, 95% CI: 0.17-0.59, p < 0.001). Almost two in three of the female sex workers in Gulu city were currently using PrEP. Previous use of PEP was associated with lower use of PrEP. These findings suggest the need for targeted interventions to increase PrEP uptake and decrease HIV acquisition in this high-risk population among female sex workers, especially those with low income and limited access to healthcare.

The Relationship Between HIV Pre-exposure Prophylaxis Stigma and Treatment Adherence Among Current HIV Pre-exposure Prophylaxis Users in the Southeastern U.S.

Despite efficacy in HIV prevention, Pre-exposure Prophylaxis (PrEP) is underutilized in the US, especially among populations at highest risk. PrEP-related stigma may play a role. We developed measures of PrEP-related stigma dimensions and PrEP adherence. We administered them to current PrEP users. We hypothesized that PrEP-related stigma would negatively impact PrEP adherence. Questionnaire measures were developed using data from previous qualitative work and existing validated HIV-related stigma measures. The resultant survey was administered to current PrEP users from two Birmingham, Alabama PrEP clinics. Plasma tenofovir disoproxil fumarate levels were collected to measure PrEP adherence. Exploratory factor analyses were performed to determine the factor structure of each PrEP-related stigma dimension (internalized, perceived, experienced, anticipated, disclosure concerns). Separate binary logistic (or linear) regressions were performed to assess associations between PrEP-related stigma dimensions and adherence (treatment adherence self-efficacy, self-reported adherence, and plasma tenofovir levels), adjusting for education, race, and time on PrEP. In 2018, 100 participants completed the survey, with 91 identifying as male and 66 as white. Only internalized stigma was associated with lower self-reported PrEP adherence. Exploratory mediation analyses suggested that the association between all stigma dimensions and self-reported PrEP adherence is mediated by PrEP adherence self-efficacy. No associations were found between any PrEP-related stigma measures and plasma tenofovir levels. Internalized PrEP stigma may reduce PrEP adherence, possibly by reducing PrEP adherence self-efficacy among experienced PrEP users. Further investigation of how stigma dimensions affect PrEP adherence in populations at risk for HIV may shed light on drivers of PrEP underutilization.

Integrating Enhanced HIV Pre-exposure Prophylaxis Into a Sexually Transmitted Infection Clinic in Lilongwe: Protocol for a Prospective Cohort Study.

Pre-exposure prophylaxis (PrEP) reduces HIV acquisition risk by >90% and is a critical lever to reduce HIV incidence. Identifying individuals most likely to benefit from PrEP and retaining them on PrEP throughout HIV risk is critical to realize PrEP's prevention potential. Individuals with sexually transmitted infections (STIs) are an obvious priority PrEP population, but there are no data from sub-Saharan Africa (SSA) confirming the effectiveness of integrating PrEP into STI clinics. Assisted partner notification may further enhance STI clinic-based PrEP programming by recruiting PrEP users from the pool of named sexual partners of individuals presenting with an incident STI. However, the acceptability, feasibility, and effectiveness of these integrated and enhanced strategies are unknown. This study aims to describe the implementation outcomes of acceptability, feasibility, and effectiveness (regarding PrEP uptake and persistence) of integrating an enhanced PrEP implementation strategy into an STI clinic in Malawi. The enhanced PrEP STI study is a prospective cohort study enrolling patients who are eligible for PrEP (aged ≥15 years) who are seeking STI services at a Lilongwe-based STI clinic. Data collection relies on a combination of in-depth interviews, patient and clinic staff surveys, and clinic record review. All enrolled PrEP users will be screened for acute HIV infection and receive quarterly testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis. Participants will be asked to name recent sexual partners for assisted notification; returning partners will be screened for PrEP eligibility and, if interested, enrolled into the cohort of PrEP initiators. We will also enroll patients who are eligible for PrEP but choose not to initiate it, from the STI clinic. Patient participants will be followed for 6 months; we will assess self-reported PrEP use, PrEP refills, sexual behaviors, perceived HIV risk, and incident STIs. Clinic staff participants will be interviewed at baseline and at approximately 6 months and will complete surveys examining the perceived acceptability and feasibility of the integrated and enhanced PrEP strategy. Enrollment began in March 2022 and is projected to continue until February 2023, with patient participant follow-up through August 2023. The results of this study are expected to be reported in 2024. This study will generate important evidence regarding the potential integration of PrEP services into STI clinics in SSA and preliminary data regarding the effectiveness of an enhanced intervention that includes assisted partner notification as a strategy to identify potential PrEP users. Furthermore, this trial will provide some of the first insights into STI incidence among PrEP users recruited from an STI clinic in SSA-critical data to inform the use of etiologic STI testing where syndromic management is the current standard. These findings will help to design future PrEP implementation strategies in SSA. ClinicalTrials.gov NCT05307991; https://clinicaltrials.gov/ct2/show/NCT05307991. DERR1-10.2196/37395.

Alignment of PrEP use and sexual behavior over four months among men who have sex with men in the southern United States.

Unlike antiretrovirals for HIV treatment, pre-exposure prophylaxis (PrEP) does not require continual adherence to be fully effective; rather, PrEP adherence is important only in the context of episodes of sexual risk. Therefore, studies of PrEP adherence and persistence must incorporate contemporaneous measurement of sexual behavior. Short, frequent surveys of PrEP use and sexual behavior allow for the measurement of the alignment between PrEP use and sexual behavior. We assessed the feasibility of using biweekly PrEP use and sexual behavior questionnaires to measure adherence and persistence on PrEP over a period of four months. We also measured the alignment of PrEP use and condomless anal sex. PrEP-using MSM in the southern US were recruited using online advertisements. Participants completed a baseline survey followed by brief surveys every two weeks for 16 weeks to report their PrEP use and sexual behavior over the preceding two-week period. Study retention was high: 91% of participants completed the baseline and final survey and, overall, 86% of study surveys were completed. Self-reported PrEP adherence and persistence were high, but instances of PrEP non-adherence were observed to frequently overlap with episodes of condomless anal sex. The most prominent reasons cited for missing PrEP doses were being too busy, not having PrEP on hand, and not being sexually active. Completing short, biweekly surveys of PrEP use and sexual behavior is feasible and acceptable to MSM in the southern US. Future studies should investigate incorporating biomarker measurements to validate self-reported adherence.

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis.

Poor adherence to oral HIV pre-exposure prophylaxis (PrEP) diminishes its clinical and public health benefits. This study synthesises evidence regarding discontinuation, adherence, and reinitiation of PrEP among geographically diverse PrEP users. We did a systematic review and meta-analysis evaluating studies published in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to Dec 18, 2020. We included longitudinal studies that presented data for PrEP discontinuation, defined as investigator-reported loss to follow-up or participant self-reported PrEP stoppage. Data were extracted from published reports and assessed for risk of bias. We used a random-effects meta-analysis to pool estimates of discontinuation and I2 and τ2 to evaluate heterogeneity. This study is registered with PROSPERO, CRD42020155675. We identified 4129 records, of which 59 articles were included (n=43 917 participants). 41·0% (95% CI 18·8-63·5) of participants discontinued PrEP within 6 months, with the highest rates in observational studies. The discontinuation rate in sub-Saharan Africa (47·5%, 95% CI: 29·4-66·4%) was higher than in other regions (p<0·001). Discontinuation rates were lower in studies with adherence interventions than in those without (24·7% vs 36·7%, p=0·015). Gay or bisexual men who have sex with men and transgender women offered daily or non-daily dosing options had lower discontinuation rates than those offered daily dosing alone (21·6% vs 31·5%; p<0·001). The pooled suboptimal adherence within 6 months was 37·7% (95% CI 8·4-66·9). Among people who discontinued PrEP, 47·3% (95% CI 31·5-63·2) reinitiated PrEP within 1 year of PrEP initiation. The included studies had poor quality in terms of study design, with a moderate risk of bias. Strategies to encourage reinitiating PrEP for new or persistent risk should be a focus of future PrEP implementation strategies. National Institutes of Health and Nature Science Foundation of China.

865. Social Media Secret Facebook Groups for HIV Pre-Exposure Prophylaxis Awareness among Female Sex Workers in Cameroon

BackgroundAbout 25% of Cameroonian female sex workers (FSW) lived with HIV in 2018. PrEP was introduced in Cameroon in 2019, with minimal uptake as of 2021. The goal of this pilot project was to evaluate the potential of a novel social media intervention to raise Pre-Exposure Prophylaxis (PrEP) awareness and complement HIV prevention strategies among FSW, a key risk population.MethodsFrom October 2020 to April 2021, sixty adult HIV-negative FSW who owned a phone with internet access joined the study; 40 in the intervention arm and 20 in the control arm. The intervention had a Secret Facebook Group (SFG) platform for confidentiality. It included 12 videos on HIV prevention in the local dialect, released over 8 weeks. In-person surveys were administered before and after the intervention, and three months later. Likert scale was used to evaluate the main outcome: PrEP awareness. Data was analyzed using Stata IC/version 14.2.ResultsDemographic characteristics were similar between intervention and control groups for age (29 years, SD7.3), literacy (45% secondary school), parity (1.9, SD1.5), and years as sex worker (7.8, SD5.1). One FSW had heard about PrEP before the intervention. After a brief introduction, 39% (15/38) of FSW in the intervention group and 50% (10/20) in the control group strongly agreed to be interested in taking PrEP (p=0.2). Baseline PrEP knowledge was poor in the intervention group (15/40, 38%) and very poor in the control group (19/20,95%) (p=0.0001). In the second survey, the intervention and control groups’ PrEP knowledge improved (p=0.0001 and p=0.02, respectively). It was more significant in the intervention group, with all FSW reporting good level of knowledge (p=0.0001) (Figure 1). In addition, more FSW in the intervention group (67%,27/40) strongly agreed to be interested in taking PrEP (p=0.01), while numbers remained similar in the control group (55%, 11/20, p=0.8). Three months after the intervention, 31.5% (12/38) of participants reported excellent PrEP knowledge, a significant improvement since the second survey (p=0.02).Figure 1. Self-reported Pre-Exposure Prophylaxis knowledge before and after intervention in the intervention and control groups. ConclusionThe use of a social media HIV prevention tool tailored to FSW in Cameroon improved PrEP awareness with good retention of knowledge. Cross contamination between groups might have hindered the differential impact of the brief intervention. Disclosures All Authors: No reported disclosures

Expanding the Pie-Differentiated PrEP Delivery Models to Improve PrEP Uptake in the San Francisco Bay Area.

Background:Pre-exposure prophylaxis (PrEP) uptake among trans people to date has been low. Recommendations implemented in San Francisco to offer PrEP with feminizing hormones have not led to improvement of PrEP uptake in trans communities. New delivery models may be needed. The aim of this study was to examine whether a PrEP-only clinic was more likely to serve trans people at highest risk of HIV than trans-affirming primary care clinics.Methods:Participants were recruited between 2017 and 2019 as part of a PrEP demonstration project in the San Francisco Bay Area. Survey data including sociodemographics, HIV-related risk behavior, barriers to PrEP, and self-reported PrEP adherence were collected at baseline, 3 months, and 6 months for all participants. Bivariable Poisson regression models were used to examine differences between participants in the primary care clinics and PrEP-only clinic delivered to participants.Results:Baseline survey data were collected from 153 participants. Those with a higher number of sexual partners were significantly more likely to use the PrEP-only clinic rather than the primary care clinics. Participants with higher perceived HIV risk and those who engaged in sex work were also more likely to use the PrEP-only clinic compared with the primary care clinic. Medical mistrust was higher at baseline among participants of the PrEP-only clinic. PrEP adherence was not significantly different by delivery model. Few participants identified PrEP barriers, such as interactions with feminizing hormones, to be determinants of PrEP uptake.Conclusions:A PrEP-only delivery model could improve PrEP uptake and may better meet the needs of trans people who could most benefit from PrEP.

MHealth for pre-exposure prophylaxis adherence by young adult men who have sex with men.

Young adult men who have sex with men (YMSM) are at increased risk for HIV, especially minority YMSM. Pre-exposure prophylaxis (PrEP) is a breakthrough daily pill to prevent HIV. Consistent adherence is key to PrEP effectiveness, which is why the CDC recommends adherence support be provided to all PrEP patients. Mobile health can overcome barriers to the delivery of adherence support, particularly for YMSM who may be most in need of it due, at least in part, to their young age. We created a culturally- and developmentally-sensitive PrEP adherence mobile app (called "Dot") that was tailored for culturally-diverse young adult MSM. After formative research and usability testing, we conducted a 6-week pre-post study to evaluate the impact of Dot on self-reported PrEP adherence, PrEP treatment self-efficacy, PrEP knowledge, and intention to practice safe sex among culturally-diverse YMSM, age 20-29. At 6 weeks, there were significant improvements in PrEP adherence, PrEP self-efficacy, and intention to practice safe sex. PrEP knowledge scores did not significantly change. The Dot app proved feasible and effective at improving PrEP adherence among culturally-diverse YMSM. Moreover, the app had a high-degree of user appeal, which is foundational to success of an mhealth intervention.

How Can We Support the Use of Oral PrEP Among Young Women who Sell Sex? A PrEP Cascade Analysis.

We constructed self-reported pre-exposure prophylaxis (PrEP) cascades and explored factors associated with and barriers to PrEP use to inform efforts to support PrEP use among young women who sell sex. Using self-reported data from HIV-negative young women who sell sex enrolled into a cohort study using respondent-driven sampling in Zimbabwe, we constructed PrEP cascades assessing knowledge of, ever offered, ever used, and current PrEP use in 2017 and 2019. We used logistic regression to examine factors associated with PrEP use by 2019. Through qualitative interviews with 43 women enrolled in the cohort, we investigated barriers to PrEP use. At enrollment, 50% of women had heard of PrEP, 12% had ever been offered PrEP, and 7% ever used PrEP. Over time, all cascade domains: 96% of women had heard of and 55% reported an active offer of PrEP. Among women retained in the study in 2019 (56%; n = 538), 34% ever took PrEP by 2019. PrEP use was associated with, at enrollment, reporting more clients in the past month (10+: 45% vs 1-3: 27% adjOR = 1.71 95% CI: 1.06 to 2.76), duration of selling sex (24% <2 years vs 38% 2-3 years; adjOR = 0.51 95% CI: 0.32 to 0.83), and having visited a female sex worker program in the past 12 months (55% vs 27%; adjOR = 2.92 95% CI: 1.91 to 4.46). Qualitative interviews revealed fear of disclosing sex work, HIV-related/ART-related stigma, and (opportunity) costs of accessing PrEP as barriers to use. PrEP use was associated with factors known to increase HIV risk. Fear of stigma, disclosure, and supply-side barriers need to be addressed to increase women's ability to use PrEP.

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application.

Improving adherence to preexposure prophylaxis (PrEP) by providing automated feedback on self-reported PrEP use via a mobile application (app). Randomized clinical trial among MSM participating in the Amsterdam PrEP demonstration project (AMPrEP). Eligible participants were randomized 1 : 1 to the control or intervention app. Both allowed daily reporting of sexual behaviour and medication intake; the intervention app also provided visual feedback. Dried blood spots collected at 12 and 24 months yielded intracellular tenofovir diphosphate concentrations (TFV-DP). We assessed proportions of participants with poor (TFV-DP <700 fmol/punch; primary outcome), good (TFV-DP ≥700 fmol/punch) and excellent (TFV-DP ≥1250 fmol/punch; secondary outcome) adherence at both time-points, and the association with the control or intervention app. We randomized 229 participants, 118 to the intervention and 111 to the control arm. The primary, per-protocol, analysis included 83 participants per arm. In total, 22/166 (13%) of participants adhered poorly, 144/166 (87%) good and 66/166 (40%) excellently. App feedback did not result in a lower proportion of participants with poor adherence [control: 9 of 83 (11%); intervention: 13 of 83 (16%); P = 0.36]. App feedback did result in a larger proportion of participants with excellent adherence [control: 26/83 (31%); intervention: 40/83 (48%); P = 0.026]. In this highly adherent population, app feedback did not improve the proportion of participants with poor adherence to PrEP.Clinical Trial Number Netherlands Trial Register: NL5413.